Data / Medical devices / Germany / Xenios AG
Xenios AG: FDA-registered device maker in Stolberg North Rhine-Westphalia, Germany, 2 510(k) clearances
Xenios AG is registered with the FDA (registration 3002845651) in Stolberg North Rhine-Westphalia, Germany. It lists 3 device types. The FDA files 2 510(k) clearances under its listings, the newest dated April 15, 2024. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3002845651
- Address
- Obere Steinfurt 8-10, Stolberg North Rhine-Westphalia, Germany, 52222
- Owner or operator
- Xenios AG (10045964)
- Roles
- Manufacturer
- First device listed
- March 10, 2020
- Registered through
- 2026
- Brand names listed
- Compact holder, Extracorporeal system for long-term respiratory / cardiopulmonary failure, Flow Sensor 3/8x3/32, IPS Pressure Sensor connecting cable, Infusion Stand compact, Novalung Console, Novalung System, Novalung battery pack and more
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Extracorporeal System For Long-Term Respiratory / Cardiopulmonary Failure | QJZ | 2 | Manufacturer | accessdata.fda.gov |
| Oxygenator, Long Term Support Greater Than 6 Hours | BYS | 2 | Manufacturer | accessdata.fda.gov |
| Tubing, Long Term Support Greater Than 6 Hours | QWF | 2 | Manufacturer | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| April 15, 2024 | K232926 | Novalung ultimate kit (US) | QJZ | Substantially Equivalent | Fresenius Medical Care Renal Therapies Group, LLC | accessdata.fda.gov |
| February 21, 2020 | K191407 | Novalung System | QJZ | Substantially Equivalent | Fresenius Medical Care Renal Therapies Group, LLC | accessdata.fda.gov |
Compare with other makers
- All makers of Extracorporeal System For Long-Term Respiratory / Cardiopulmonary Failure
- All makers of Tubing, Long Term Support Greater Than 6 Hours
- All makers of Oxygenator, Long Term Support Greater Than 6 Hours
Updated April 15, 2024. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.